Surgical Methods for Uterine Septum

Overseen By Sarah L Rodriguez, MD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Northwestern University

Must not be taking: Blood thinners

Disqualifiers: Tubal disease, Bleeding diastasis, Fibroids, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: During the surgery

40 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot be on blood thinners to participate.

What data supports the effectiveness of this treatment for uterine septum?

Research shows that hysteroscopic septoplasty, which involves removing a uterine septum, is a safe and effective treatment for improving pregnancy outcomes in women with a septate uterus. It is associated with better reproductive outcomes, such as reduced recurrent miscarriages and improved live birth rates, compared to traditional surgical methods. ^{1 2 3 4 5}

Is hysteroscopic surgery for uterine septum generally safe?

Hysteroscopic surgery for uterine septum, such as metroplasty, is generally considered safe with low risk of complications when performed by trained professionals. However, there is a rare risk of uterine rupture during a future pregnancy after the procedure. ^{1 3 5 6 7}

How does hysteroscopic septoplasty differ from other treatments for uterine septum?

Hysteroscopic septoplasty is unique because it is a minimally invasive procedure that uses a hysteroscope (a thin, lighted tube) to remove the uterine septum, either with scissors or bipolar electrosurgery, avoiding the need for more invasive abdominal surgery. This approach is associated with lower risk and quicker recovery, making it the preferred treatment for uterine septa. ^{1 5 7 8 9}

What is the purpose of this trial?

The objective of this study is to determine if the use of scissors without electrosurgery is superior to bipolar electrosurgery for resection of uterine septum. The investigators will be comparing procedure-level variables such as operative time, complications, and need for additional procedures.

Eligibility Criteria

This trial is for individuals with a uterine septum, which is an extra piece of tissue in the uterus. Participants should not have any other health issues that could complicate surgery. The study aims to find out if removing this tissue without using electricity (electrosurgery) is better than the current method.

Inclusion Criteria

I am between 20 and 44 years old.

My MRI or 3D imaging shows a septum thicker than 1.0 cm.

Exclusion Criteria

I am not taking any blood thinners.

I do not have a laparoscopy planned.

I have a diagnosed condition affecting my fallopian tubes.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo hysteroscopic septoplasty using either bipolar electrosurgery or scissors without electrosurgery

During the surgery

Follow-up

Participants have a routine follow-up visit to assess septum resolution and potential need for additional procedures

4 weeks

1 visit (in-person)

Post-operative Monitoring

Participants' recovery and satisfaction are assessed with follow-up phone calls

1 week

Treatment Details

Interventions

• Hysteroscopic septoplasty utilizing bipolar electrosurgery
• Removal of uterine septum with hysteroscopic scissors without electrosurgery

Trial Overview The study compares two surgical methods for treating a uterine septum: one uses scissors without electrosurgery and the other uses bipolar electrosurgery. It will look at how long the surgery takes, what complications might occur, and whether additional procedures are needed afterwards.

Participant Groups

Group I: Study Intervention B (study group) Experimental Treatment 1 Intervention

Hysteroscopic septoplasty utilizing scissors without electrosurgery followed by hysteroscopic morcellation of residual tissue

Group II: Study Intervention A (control group) Active Control 1 Intervention

Hysteroscopic septoplasty utilizing bipolar electrosurgery

Hysteroscopic septoplasty utilizing bipolar electrosurgery is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Hysteroscopic septoplasty for:

• Uterine septum
• Infertility
• Abnormal uterine bleeding

Approved in United States as Hysteroscopic septoplasty for:

• Uterine septum
• Infertility
• Abnormal uterine bleeding
• Recurrent miscarriage

Approved in Canada as Hysteroscopic septoplasty for:

• Uterine septum
• Infertility
• Abnormal uterine bleeding

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Findings from Research

Hysteroscopic metroplasty, a minimally invasive surgical technique, was successfully performed on 11 patients with septate uterus, showing good surgical outcomes without any intra- or postoperative complications.

The initial results suggest that if pregnancy outcomes improve as expected, hysteroscopic metroplasty could replace traditional abdominal surgery as the preferred treatment for uterine septa, potentially reducing recovery time and risks associated with more invasive procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hysteroscopic treatment of uterine septa. Perino, A., Cittadini, E., Hamou, J., et al.[2004]

Hysteroscopic septoplasty is an effective procedure for treating a septate uterus, particularly beneficial for women with recurrent pregnancy losses, potentially improving live birth rates.

While enlarging hysteroscopic metroplasty shows promise in enhancing obstetrical outcomes for certain uterine malformations, evidence is insufficient to recommend it as a first-line treatment except in specific cases, such as older women or prior to assisted reproductive techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Do hysteroscopic metroplasties really improve really reproductive outcome?]. Garbin, O., Ziane, A., Castaigne, V., et al.[2013]

Hysteroscopic metroplasty, a procedure to improve pregnancy outcomes for women with a uterine septum, carries a risk of uterine rupture during subsequent pregnancies, as demonstrated by a case of a patient experiencing this complication at 28 weeks.

Despite being rare, the occurrence of uterine rupture after this procedure highlights the need for patients to be informed about this potential risk in future pregnancies, although strategies to prevent such complications remain unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spontaneous uterine rupture with amniotic sac protrusion at 28 weeks subsequent to previous hysteroscopic metroplasty. Conturso, R., Redaelli, L., Pasini, A., et al.[2019]

Sectioning the cervical septum during hysteroscopic metroplasty significantly reduces operating time and the amount of distending media used, making the procedure safer and easier compared to preserving the cervical septum.

The study found that while there were some complications, such as significant bleeding in the group that preserved the cervical septum, there were no significant differences in reproductive outcomes between the two groups, suggesting that resection is a viable option for women with a complete uterine septum.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hysteroscopic metroplasty of the complete uterine septum, duplicate cervix, and vaginal septum. Parsanezhad, ME., Alborzi, S., Zarei, A., et al.[2006]

In a review of 125 patients, hysteroscopic septoplasty using scissors resulted in a higher pregnancy rate (88.8%) compared to the resectoscope (75.6%), but this difference was not statistically significant.

Overall, there were no significant differences in reproductive outcomes, including delivery rates and miscarriage rates, between the two techniques, indicating that both methods are similarly effective for treating a septate uterus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reproductive outcome after operative hysteroscopy for uterine septum: scissors or diathermy? Daniilidis, A., Kalpatsanidis, A., Kalkan, U., et al.[2020]

Hysteroscopic metroplasty significantly improved reproductive outcomes in women with a septate uterus, with live birth rates increasing from 3.7% to 84.6% after surgery, and clinical pregnancy rates rising from 69.5% to 78.2%.

Factors such as age (≥ 35 years) and primary infertility were identified as independent risk factors negatively affecting postoperative clinical and ongoing pregnancy outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reproductive outcomes and risk factors of women with septate uterus after hysteroscopic metroplasty. Chang, Y., Shen, M., Wang, S., et al.[2023]

Hysteroscopic metroplasty is the gold standard treatment for uterine septa, which affects about 1% of infertile women and 3.3% of those with repeated fetal losses, offering a low-morbidity option for correction.

While complications from the procedure are rare, there is a potential risk of uterine rupture following the resection of a uterine septum, highlighting the need for careful patient selection and monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Septate uterus: role of hysteroscopic metroplasty]. Lourdel, E., Cabry-Goubet, R., Merviel, P., et al.[2007]

In a study involving 10 women with complete septate uterus, the technique of incising the cervical septum under hysteroscopic guidance was found to be simple, rapid, and safe, with an average procedure time of 24 minutes and no significant intraoperative bleeding.

Postoperative follow-up showed that all patients had competent cervices and did not experience any second-trimester abortions or premature deliveries, indicating that this technique is effective and does not lead to major obstetric complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metroplasty for the complete septate uterus: does cervical sparing matter? Vercellini, P., De Giorgi, O., Cortesi, I., et al.[2019]

Complicated hysteroscopic metroplasty can lead to acute uterine rupture during pregnancy and labor, highlighting the need for careful monitoring of patients who have undergone this procedure.

Ultrasound is an effective tool for detecting uterine lesions, which could help in managing labor more safely, especially in cases where prostaglandin (PGE2) is contraindicated after such surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Uterine rupture after hysteroscopic metroplasty and labor induction. A case report. Gabriele, A., Zanetta, G., Pasta, F., et al.[2016]

References

1. Italy pubmed.ncbi.nlm.nih.gov

Hysteroscopic treatment of uterine septa. [2004]

2. France pubmed.ncbi.nlm.nih.gov

[Do hysteroscopic metroplasties really improve really reproductive outcome?]. [2013]

3. Ireland pubmed.ncbi.nlm.nih.gov

Spontaneous uterine rupture with amniotic sac protrusion at 28 weeks subsequent to previous hysteroscopic metroplasty. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Hysteroscopic metroplasty of the complete uterine septum, duplicate cervix, and vaginal septum. [2006]

5. Italy pubmed.ncbi.nlm.nih.gov

Reproductive outcome after operative hysteroscopy for uterine septum: scissors or diathermy? [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Reproductive outcomes and risk factors of women with septate uterus after hysteroscopic metroplasty. [2023]

7. France pubmed.ncbi.nlm.nih.gov

[Septate uterus: role of hysteroscopic metroplasty]. [2007]

8. United States pubmed.ncbi.nlm.nih.gov

Metroplasty for the complete septate uterus: does cervical sparing matter? [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Uterine rupture after hysteroscopic metroplasty and labor induction. A case report. [2016]